(196 days)
Jiajian Acupuncture Needle is intended to piece the skin in the practice of acupuncture therapy by qualified practitioners or acupuncture doctors as determined by the states.
Jiajian brand Acupuncture Needle consists of a stainless steel wire (ASTM 304) as the needle body, with a stainless steel wire handle, a copper wire handle or polystyrol handle. The handles make the needles easier to manipulate and place. The acupuncture needle is sterilized and disposable. The diameter of the needle is 0.140.80mm; the length of the needle is 7100mm; the invasive length is 2~47mm.
The provided text is a 510(k) Premarket Notification Summary for the Jiajian Acupuncture Needle. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies with acceptance criteria and statistical analysis typical of software or AI/ML medical devices. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics. The primary "performance" demonstrated is the substantial equivalence to predicate devices. This means the device is considered as safe and effective as the predicate devices.
2. Sample size used for the test set and the data provenance
No test set for performance evaluation in the typical sense (e.g., a dataset of images for an AI model) is described. The device is a physical acupuncture needle.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no such test set or ground truth determination process is described for this physical medical device.
4. Adjudication method for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
Not applicable. The "ground truth" for this submission is establishing that the device's design, materials, and intended use are similar enough to existing legally marketed devices.
8. The sample size for the training set
Not applicable, as this is a physical device and not an AI/ML model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and Substantial Equivalence Information (from the provided text):
The Jiajian Acupuncture Needle is a single-use acupuncture needle made of stainless steel wire with various handle options. It is sterilized by Co-60 irradiation and intended for use by qualified practitioners for acupuncture therapy.
The manufacturer claims substantial equivalence to two predicate devices:
Similarities claimed between the Jiajian Acupuncture Needle and predicate devices:
- Similar materials composition and structure.
- Same intended use.
- All are sterile.
- All are used as prescription.
Differences:
- Different sizes scale (This difference was not deemed significant enough to preclude substantial equivalence).
The FDA concurred with the substantial equivalence determination.
§ 880.5580 Acupuncture needle.
(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.